NCT02702466

Brief Summary

The main objective of this work is to demonstrate superiority to three months of a standardized short course of SPA Therapy of 6 days associated with personalized health education program compared to conventional therapy in the management of MSDs on the functional capabilities of the employees in their daily lives (personal or professional)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

2.4 years

First QC Date

March 3, 2016

Last Update Submit

June 26, 2018

Conditions

Keywords

Upper limb musculoskeletal disordersSpa treatmentRandomized controlled trialsEducationSelf- managementSelf-careExerciseNon pharmacological treatment

Outcome Measures

Primary Outcomes (1)

  • The score from the scale Quick DASH

    Change from baseline in measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb by Quick DASH measure

    Month 03

Secondary Outcomes (4)

  • Change of Quick DASH

    Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06

  • Pain intensity

    Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06

  • Life quality

    Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06

  • Stopping time of work

    Month 06

Study Arms (2)

Immediate SPA Therapy

EXPERIMENTAL

6 day immediate SPA treatment (soon after randomization) and written information with physical exercises adapted to their pathology and also a program of healthcare at the USB key

Other: SPA Therapy

Late SPA Therapy

ACTIVE COMPARATOR

Written information with physical exercises adapted to their pathology and a program of healthcare at the USB key and late 6 day SPA treatment

Other: SPA Therapy

Interventions

Immersion bath and shower ( 1 treatment ) Underwater shower with localized massage on the painful area ( 1 treatment ) or equivalent underwater massage Illutations ( 1 treatment ) or equivalent ( poultice ) Mobilization Pool ( 1 care) Education to exercise

Also known as: Non pharmacological intervention
Immediate SPA TherapyLate SPA Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • TMS latent or symptomatic of the upper limbs according to the European Consensus SALTSA / Q score with INRS Nordic \> 2
  • Age: \> 18 years \< 65 years
  • Patient affiliated to a social security scheme ( beneficiary entitled )
  • Patient has given its consent in writing to participate in the study

You may not qualify if:

  • Contraindication to the spa therapy
  • Spa achieved in the last 12 months
  • Trouble behavior or understanding making it impossible to assess

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Etablissement thermal

Aix-les-Bains, Auvergne-Rhône-Alpes, 73100, France

Location

Etablissement thermal

Châtel-Guyon, Auvergne-Rhône-Alpes, 63140, France

Location

Etablissement thermal

Royat, Auvergne-Rhône-Alpes, 63408, France

Location

Etablissement thermal

Saint-Amand-les-Eaux, Hauts-de-France, 59230, France

Location

Etablissement thermal

Balaruc-les-Bains, Occitanie, 34540, France

Location

Related Publications (11)

  • McBeth J, Jones K. Epidemiology of chronic musculoskeletal pain. Best Pract Res Clin Rheumatol. 2007 Jun;21(3):403-25. doi: 10.1016/j.berh.2007.03.003.

    PMID: 17602991BACKGROUND
  • Kamaleri Y, Natvig B, Ihlebaek CM, Bruusgaard D. Localized or widespread musculoskeletal pain: does it matter? Pain. 2008 Aug 15;138(1):41-46. doi: 10.1016/j.pain.2007.11.002. Epub 2008 Feb 20.

    PMID: 18077092BACKGROUND
  • Solidaki E, Chatzi L, Bitsios P, Markatzi I, Plana E, Castro F, Palmer K, Coggon D, Kogevinas M. Work-related and psychological determinants of multisite musculoskeletal pain. Scand J Work Environ Health. 2010 Jan;36(1):54-61. doi: 10.5271/sjweh.2884. Epub 2009 Dec 11.

    PMID: 20011982BACKGROUND
  • Fan ZJ, Smith CK, Silverstein BA. Assessing validity of the QuickDASH and SF-12 as surveillance tools among workers with neck or upper extremity musculoskeletal disorders. J Hand Ther. 2008 Oct-Dec;21(4):354-65. doi: 10.1197/j.jht.2008.02.001.

    PMID: 19006762BACKGROUND
  • Polson K, Reid D, McNair PJ, Larmer P. Responsiveness, minimal importance difference and minimal detectable change scores of the shortened disability arm shoulder hand (QuickDASH) questionnaire. Man Ther. 2010 Aug;15(4):404-7. doi: 10.1016/j.math.2010.03.008.

    PMID: 20434942BACKGROUND
  • Fayad F, Lefevre-Colau MM, Gautheron V, Mace Y, Fermanian J, Mayoux-Benhamou A, Roren A, Rannou F, Roby-Brami A, Revel M, Poiraudeau S. Reliability, validity and responsiveness of the French version of the questionnaire Quick Disability of the Arm, Shoulder and Hand in shoulder disorders. Man Ther. 2009 Apr;14(2):206-12. doi: 10.1016/j.math.2008.01.013. Epub 2008 Apr 23.

    PMID: 18436467BACKGROUND
  • Fayad F, Lefevre-Colau MM, Mace Y, Fermanian J, Mayoux-Benhamou A, Roren A, Rannou F, Roby-Brami A, Gautheron V, Revel M, Poiraudeau S. Validation of the French version of the Disability of the Arm, Shoulder and Hand questionnaire (F-DASH). Joint Bone Spine. 2008 Mar;75(2):195-200. doi: 10.1016/j.jbspin.2007.04.023. Epub 2007 Aug 30.

    PMID: 17983829BACKGROUND
  • Meroni R, Scelsi M, Boria P, Sansone V. Shoulder disorders in female working-age population: a cross sectional study. BMC Musculoskelet Disord. 2014 Apr 4;15:118. doi: 10.1186/1471-2474-15-118.

  • Parot-Schinkel E, Descatha A, Ha C, Petit A, Leclerc A, Roquelaure Y. Prevalence of multisite musculoskeletal symptoms: a French cross-sectional working population-based study. BMC Musculoskelet Disord. 2012 Jul 20;13:122. doi: 10.1186/1471-2474-13-122.

  • Lanhers C, Grolier M, Dutheil F, Gay C, Goldstein A, Mourgues C, Levyckyj C, Pereira B, Coudeyre E. Comparison of self-management and spa therapy for upper-extremity musculoskeletal disorders: A randomized controlled trial. Ann Phys Rehabil Med. 2024 Apr;67(3):101813. doi: 10.1016/j.rehab.2023.101813. Epub 2024 Mar 12.

  • Lanhers C, Pereira B, Gay C, Herisson C, Levyckyj C, Dupeyron A, Coudeyre E. Evaluation of the efficacy of a short-course, personalized self-management and intensive spa therapy intervention as active prevention of musculoskeletal disorders of the upper extremities (Muska): a research protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2016 Dec 9;17(1):497. doi: 10.1186/s12891-016-1353-8.

MeSH Terms

Conditions

Musculoskeletal DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Emmanuel COUDEYRE, PhD

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2016

First Posted

March 8, 2016

Study Start

September 1, 2015

Primary Completion

February 1, 2018

Study Completion

May 1, 2018

Last Updated

June 27, 2018

Record last verified: 2018-06

Locations